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This is a prospective, randomized, open-label, blinded end-point evaluation trial. The patient population consists of patients on hemodialysis who have atrial fibrillation (AF) and end-stage renal disease (ESRD) .

Condition or disease

Intervention/treatment

Phase

Atrial FibrillationEnd Stage Renal Disease

Drug: apixabanDrug: warfarin

Phase 4

Detailed Description:

This is a multicenter study in adult patients with AF and ESRD who are on hemodialysis and who have stroke risk factors making them candidates for oral anticoagulation. Patients will be randomized to apixaban versus warfarin, and will be treated for up to 15 months.

Time (measured in days) from randomization to the onset of first major bleeding/clinically relevant non-major bleeding event, as described by International Society of Thrombosis and Haemostasis (ISTH) [ Time Frame: 15 months ]

Secondary Outcome Measures :

stroke or systemic embolism [ Time Frame: 15 months ]

mortality [ Time Frame: 15 months ]

all-cause death

adherence to treatment with apixaban or with warfarin, measured by pill count for patients randomized to apixaban, and by time in therapeutic range (TTR) for warfarin [ Time Frame: 15 months ]

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Ages Eligible for Study:

18 Years and older (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Males and females, age at least 18 years, or the local age of consent, whichever is greater.

Patients with AF defined as AF on ECG at enrollment or two or more reports of AF from separate monitoring events at least 2 weeks apart (report of ECG, Holter monitor, event monitor or implantable loop recorder).

CHA2DS2-VASc score of ≥ 2.

End-stage renal disease treated with hemodialysis for ≥ 3 months.

Considered by the treating physician(s) to be candidate for oral anticoagulation.

If of childbearing potential, be willing to avoid pregnancy during the study.

Exclusion Criteria:

Not considered by the treating physician(s) to be candidates for oral anticoagulation (for example, hemoglobin < 8.5g/dL, history of intracranial hemorrhage, active bleeding, recent gastrointestinal bleed or retroperitoneal bleed, severe hepatic impairment, or anaphylactic reaction to apixaban)

Moderate or severe mitral stenosis

Conditions other than AF that require anticoagulation such as mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism

Need for aspirin at a dose > 81 mg a day or need for P2Y12 antagonist therapy (for example clopidogrel, prasugrel, or ticagrelor)

Life expectancy < 3 months

Anticipated kidney transplant within the next 3 months

Prisoners or others who are involuntarily incarcerated or detained

Pregnant, breastfeeding, or considering pregnancy.

Participation in a clinical trial of an experimental treatment within the past 30 days